Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Pr...

FDA Device Recall #Z-0893-2017 — Class II — October 24, 2016

Recall Summary

Recall Number Z-0893-2017
Classification Class II — Moderate risk
Date Initiated October 24, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ansell Healthcare Products LLC
Location Iselin, NJ
Product Type Devices
Quantity 15 Cartons

Product Description

Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC. 1635 Industrial Road Dothan, AL 36303, USA TEL USA- 1-800-952-9916 CAN- 1-844-494-7854 catalog #20277285

Reason for Recall

Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove.

Distribution Pattern

US Distribution to the states of : PA, FL, NJ, IL and MA.

Lot / Code Information

Lot 1607018105

Other Recalls from Ansell Healthcare Products LLC

Recall # Classification Product Date
Z-0097-2024 Class II NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical glo... Aug 3, 2023
Z-0096-2024 Class II GAMMEX NON-LATEX PI GREEN Surgical gloves, REF:... Aug 3, 2023
Z-0838-2022 Class II Gammex Non-Latex PI Green PI-KARE Skin-friendly... Feb 19, 2022
Z-0051-2021 Class II MICROFLEX Diamond Grip Examination Gloves, MF-3... Aug 19, 2020
Z-0838-2013 Class II LifeStyles ZERO 10 uber-thin lubricated latex c... Jan 14, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.